Efficacy and Safety of Micra AV2 Transcatheter Pacing System
Recruiting
N/A
Interventional Study
AV Block Complete
AV Block-2Nd Degree-Type 1
AV Block
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 150 (estimated)
- Sponsor
- Universitaire Ziekenhuizen KU Leuven · Other
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About This Trial
A third generation, Micra AV2 is now available and proposes increased automaticity and improved AV synchrony algorithms based on computing model. The new algorithms permit the delivery of AV synchronous pacing, improving the automatic AV synchrony at faster heart rates between 80-100 bpm with a maximal upper tracking rate limit of 135 bpm (previously 115-120 bpm in the Micra AV1). Micra AV2 presen…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
2. At least 18 years of age at the time of signing the Informed Consent Form (ICF)
3. Participant will be implanted with a Micr…
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